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Class I Medical Device Recall: Stryker Orthopaedics - ShapeMatch Cutting Guide

April 18, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Stryker Orthopaedics has become aware of potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides. The parameters of the manufactured cutting guides did not meet the surgeon’s pre-operative planning parameters entered via the web application.

Stryker Must Face Trident Hip Implant Lawsuit

March 22, 2013 10:49 am | by Mass Device | News | Comments

Raymond Chasse Jr. and Stephen Miele sued Kalamazoo, Mich.-based Stryker in December 2012 in the U.S. District Court for Massachusetts, alleging that the medical device company was negligent in its manufacture and distribution of the Trident hip replacement system, according to court documents.

FDA Blames Poor Training for New Deaths, Injuries Tied to Stryker's Recalled Neptune Systems

March 19, 2013 2:30 pm | by Mass Device | News | Comments

The FDA this month issued updated warnings to clinics still using Stryker's (NYSE:SYK) recalled Neptune 1 Silver or Neptune 2 Ultra surgical waste management systems, noting that there have been additional deaths and patient injuries since Stryker initiated the recall last year.


Stryker Announces the Launch of the ES2 Spinal System

March 15, 2013 9:01 am | by PR Newswire | News | Comments

ALLENDALE, N.J., March 15, 2013 /PRNewswire/ -- Stryker announced today the launch of the ES2 Spinal System. The ES2 system is built on Stryker's trusted Xia 3 pedicle screw technology, which has been used in approximately 500,000 cases worldwide. ES2's streamlined implant and...

VertiFlex®, Inc. Announces Sale of Certain Non-Core Spinal Implant Technologies to Stryker

March 13, 2013 12:46 pm | by The Associated Press | News | Comments

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Mar 13, 2013--VertiFlex®, Inc., a leading innovator of advanced minimally invasive spinal surgery technologies , today announced the sale of certain assets to Stryker Corporation’s Spine Division relating to spinal implants that are not core to the ongoing...

Stryker Gets FDA Warning Letter After Inspection

March 12, 2013 3:39 pm | by The Associated Press | News | Comments

Orthopedic maker Stryker Corp. said Tuesday that it received a warning from government regulators about quality control issues and unapproved marketing of medical devices. The company said it got the letter from the Food and Drug Administration following a November inspection of its Portage, Mich., facility.

FDA Warns Stryker on Quality Systems, Recalls, and Neptune Marketing

March 12, 2013 9:38 am | by Mass Device | News | Comments

Stryker said that the FDA sent it a warning letter stemming from an November 2012 inspection of a plant in Portage, MI. The company said the letter, based on "quality system observations," flagged it for failing to tell the agency of a product recall and for marketing devices including its Neptune waste management system without 510(k) clearance from the FDA.

Stryker Announces $250 Million Accelerated Share Repurchase Program

March 1, 2013 8:06 am | by The Associated Press | News | Comments

Kalamazoo, Michigan - March 1, 2013 - Stryker Corporation (NYSE:SYK) announced today it has entered into an Accelerated Share Repurchase agreement (ASR) with JPMorgan Chase Bank, NA to repurchase an aggregate of $250 million of the Company's common stock.  The ASR is part of the Company's existing...


Searcy Denney Scarola Barnhart & Shipley Attorney Appointed to Plaintiff's Steering Committee for Stryker Hip Implant Litigation

February 26, 2013 2:15 pm | by Bio-Medicine.Org | News | Comments

WEST PALM BEACH, Fla. , Feb. 26, 2013 /- South Florida law firm Searcy Denney Scarola Barnhart & Shipley PA ( Searcy Denney ) announced today that C. Calvin Warriner , a shareholder at the firm, was appointed to the newly established Plaintiff's Steering Committee for the Stryker Rejuvenate and ABG II hip implant Multi-County Litigation in New Jersey . Warrin...

Iowa Resident Brings Suit Against Stryker For Damages Caused By Recalled Hip Implant

February 21, 2013 5:01 pm | by The Associated Press | News | Comments

NEW YORK--(BUSINESS WIRE)--Feb 21, 2013--Wendy Fleishman and Lexi J. Hazam of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Karla Krogman of West Des Moines, Iowa, filed a lawsuit against Stryker Orthopaedics charging that the company manufactured...

Stryker Recommends More Vigilant Monitoring of Patients with Recalled Hip Implants

February 20, 2013 3:09 pm | by Mass Device | News | Comments

Stryker's Australian arm provided national health regulators with updated recommendations for monitoring patients who received the company's now-recalled ABG II Modular hip systems. Australia's Therapeutic Goods Admin. issued the new guidelines for patient follow-up, advising regular blood testing and soft tissue cross-sectional imaging for all ABG II patients, even in the absence of pain or swelling.

Emergency Nurses Association Announces Corporate Sponsors for Leadership Conference

February 18, 2013 9:28 am | by Bio-Medicine.Org | News | Comments

DES PLAINES, Ill. , Feb. 18, 2013 /PRNewswire-USNewswire/ -- The Emergency Nurses Association (ENA) today announced the corporate sponsors for the ENA Leadership Conference to be held in Fort Lauderdale on February 28- March 3, 2013. This year's Strategic Sponsors are Hill-Rom, Stryker and Vidacare; the Strategic Supporters are Blue Jay Consulting and FreemanWhite ED Design Team; and th...

Stryker to Present at Investor Conferences

February 15, 2013 1:48 pm | by The Associated Press | News | Comments

Kalamazoo, Michigan - February 15, 2013 - Stryker Corporation (NYSE:SYK) announced today that it will participate in the following investor conferences: February 25, 2013 - 10:20 a.m. Eastern Time Citi 2013 Global Healthcare Conference New York, New York March 5, 2013 - 10:40 a.m. Eastern Time...


Emerging Biologics: Breaking Down Barriers with Device Companies and the FDA

January 3, 2013 3:29 pm | by Christopher Velis | Articles | Comments

Medical devices and man-made materials have achieved major advances over recent decades. However, a new drumbeat is sounding in healthcare, as the steady growth in the use of biologics in medical procedures is gaining traction. Man-made materials will always have a place in the case of acute trauma, but biologics have the potential to take over as the most effective solution for degenerative conditions.

M&A: The top 15 acquirers among medical device companies

August 6, 2012 3:37 pm | by Mass Device | News | Comments

A look at the most acquisitive medical device companies, culled from's Big 100 database of more than 1,300 medical device industry transactions. More than $50 billion was spent on acquisitions by Big 100 medical device companies from the beginning of 2011 through the 1st half of 2012.

New Stryker Device Offers Hospitals Environmental and Bottom-line Benefits

April 17, 2012 11:48 am | News | Comments

Stryker's Sustainability Solutions division, a leader in medical device reprocessing, today introduced Restep®, the company's pioneering deep vein thrombosis (DVT) solution. Restep addresses a critical need in the market for comprehensive device solutions that deliver fiscal...

Mass. reaches $1.35M settlement with biotech co.

August 26, 2010 7:45 am | by The Associated Press | News | Comments

Massachusetts officials say a biotech company has agreed to pay $1.35 million to resolve allegations that it marketed medical products for purposes that had not been approved by regulators.Attorney General Martha Coakley said in a statement Thursday that Hopkinton-based Stryker Biotech had...

Leveraging Materials Science and Engineering Innovation to Improve Implant Performance

January 22, 2010 10:58 am | by Aiguo Wang, Ph.D. | Articles | Comments

Advances in materials are always exciting and significantly contribute to innovations in medical device technology. In the orthopedic arena, one company has developed a technique with which to enhance the material properties of polyethylene for hip and knee replacements. By Aiguo Wang, Ph.D.

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